Reported Oct 29, 2014 · Terminated

Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting…

Vygon Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vygon Corporation · 2750 Morris Rd Ste A200 · Lansdale, PA · 19446-6083

Is this the product you have?

  • Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Lot codes and dates
  • Product code and lot numbersProduct
  • Code896.038
  • with lot Numbers
    • 291113EE
    • 070214EE
    • 210314EE
    • 280314EE
Amount recalled
42250

Where it was sold

Why it was recalled

Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 30, 2015 · Data as of Sep 19, 4:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.